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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X40MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X40MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on the right side and underwent revision surgery due to screws backing out. The surgeon has concern regarding the corelock mechanism.
 
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Brand NameBLUNT TIP SCREW, 4X40MM
Type of DeviceAFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10895551
MDR Text Key217989153
Report Number0009613350-2020-00550
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K200814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-040-40
Device Lot Number3010638
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/24/2020 Patient Sequence Number: 1
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